Expertise.

CAPA Management.

Optimize your processes with quick corrective measures and preventive solutions.

Efficient?

With an optimized CAPA system, you can eliminate deviations quickly and sustainably.

Proactive?

We help you to avoid future errors through preventive measures and to continuously improve your processes.

Secure?

Ensure quality and compliance with robust CAPA management that meets all regulatory requirements.

Do you need support in implementing a CAPA management system?

CAPA-Management Consulting.

Our CAPA management helps you to efficiently rectify deviations and take preventive measures to ensure long-term compliance and quality.

Our CAPA management consulting helps you to implement an efficient system for corrective and preventive action that detects deviations at an early stage and enables sustainable process optimization. This allows you to ensure long-term compliance and product quality.

A robust CAPA system is crucial for meeting regulatory requirements in the pharmaceutical industry, medical technology and biotechnology. Our experts support you in effectively eliminating deviations and implementing preventive measures.

Our services include:

Our expertise in CAPA management.

We offer tailor-made solutions to improve quality assurance and process optimization through effective CAPA management.

Deviation analysis & corrective measures.

Preventive measures & process optimization.

Training & audit preparation.

Successful CAPA management in practice.

Our CAPA management projects show how we have helped companies in regulated industries to efficiently resolve their deviations and successfully implement preventive measures.

Challenge.

A medical technology company faced challenges when preparing for an upcoming ISO audit. Recurring deviations and a lack of documentation jeopardized the certification.

Measures.

  • Carrying out a comprehensive analysis of recurring deviations and developing customized corrective measures
  • Implementation of a CAPA system for documenting and tracking deviations
  • Training the team on the correct application of the CAPA system and preparation for audits

Results.

  • 20% reduction in deviations through targeted corrective and preventive measures
  • Successful preparation and completion of the ISO audit without any objections
  • Improved transparency and traceability thanks to optimized documentation in the CAPA system

Success.

The company successfully passed the audit and was able to improve its audit readiness in the long term.

Optimize your CAPA management for sustainable quality assurance.

Our CAPA service portfolio.

Our CAPA management service offers you comprehensive support in ensuring sustainable compliance and process optimization.
Through detailed root cause analyses and immediate corrective measures, we improve your processes and documentation to ensure sustainable auditability. These measures not only help to eliminate existing deviations, but also to ensure quality in the long term.
An important component of modern CAPA systems is the proactive analysis of deviations and the identification of trends. We support you in implementing preventive measures that not only eliminate errors, but also identify and prevent future risks. Regular risk analyses and preventive measures are central to this.

We use CAPA records to implement strategic improvements in product quality and process safety. This includes integrating CAPA management into your existing quality management system (QMS) to ensure seamless communication between departments and better data integrity. Our goal is for CAPA to be used not only reactively, but also as a strategic tool for long-term quality improvement.

Modern CAPA management software enables you to automate processes and simplify the tracking of deviations and corrective actions. This increases efficiency, improves data integrity and ensures that quality issues are identified and resolved in real time. We help you implement the right technologies to optimize your CAPA processes and meet regulatory requirements.

Achieve long-term compliance and process reliability with a structured CAPA system.

Related topics for effective CAPA management.

These supplementary services help you to implement your corrective and preventive measures efficiently and improve the quality of your processes in the long term:
ISO 13485 QM system
Ensure secure certification of your products from start to finish with ...
Complaint Management
Manage complaints efficiently and meet regulatory requirements in the life science industry.
Inspection Readiness
Ensure that your products and processes comply with regulatory requirements.
Risk Management
Identify and minimize risks with solutions for the pharmaceutical and medical technology industries.